BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    TALEISNIK TOTAL WRIST PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MGB Alert® JCV Probe Mix ASR - 48 Reactions

    FDA UDI
    Elitechgroup Mdx LLC·03661540950360·"MGB Alert® JC Virus Probe is an analyte specif...

    SONTEC SUTURE RULER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09928006020·HEARTLINE SONTEC SUTURE RULER WITH ROUND PLASTI...

    CARDIOVASCULAR NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896091351·CARDIOVASCULAR NEEDLE HOLDER TUNGSTEN CARBIDE D...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756016148·STRAP ARM SLING

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930780060200·Jacobson Forceps, 6 1/4", bayonet, 1mm, jaw 0.9...

    AUDICOR SENSOR, MODELS: 2.0, 3.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROTEGE WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    UNIVERS II HUMERAL STEM 10MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code KWS·October 14, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 8, 2014

    RESERVOIR 1.8 ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 22, 2012

    ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code GCJ·August 3, 2010

    O-ARM O2 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OWB·June 30, 2023

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015